D-0364-2024 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 13, 2024
- Initiation Date
- February 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,875 bottles
Product Description
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
Reason for Recall
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Distribution Pattern
Nationwide in the U.S. and Puerto Rico
Code Information
Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025